234 results match your criteria: "and. Clinical Statistics[Affiliation]"

Enriching single-arm clinical trials with external controls: possibilities and pitfalls.

Blood Adv

October 2023

Biostatistical Department, Hôpital Saint-Louis, Assistance Publique-Hôpitaux de Paris, Paris, France.

For the past decade, it has become commonplace to provide rapid answers and early patient access to innovative treatments in the absence of randomized clinical trials (RCT), with benefits estimated from single-arm trials. This trend is important in oncology, notably when assessing new targeted therapies. Some of those uncontrolled trials further include an external/synthetic control group as an innovative way to provide an indirect comparison with a pertinent control group.

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The Safety of the Direct Drug Provocation Test in Beta-Lactam Hypersensitivity in Children: A Systematic Review and Meta-Analysis.

J Allergy Clin Immunol Pract

February 2023

Department of Clinical Epidemiology, Faculty of Medicine, Thammasat University, Pathum Thani, Thailand; Division of Allergy and Immunology, Department of Pediatrics, Faculty of Medicine, Thammasat University, Pathum Thani, Thailand. Electronic address:

Background: Direct drug provocation test (DPT) without prior skin testing (ST) has been investigated in children suspected of being at risk for beta-lactam (BL) hypersensitivity reaction (HSR). However, no systematic review and meta-analysis has investigated the efficacy and safety of direct DPT for BL-HSR in children.

Objective: To investigate the prevalence of BL-HSR by direct DPT and the safety of direct DPT in children.

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The individualized prediction of breast cancer survival (IPBS) model was recently developed. Although the model showed acceptable performance during derivation, its external performance remained unknown. This study aimed to validate the IPBS model using the data of breast cancer patients in Northern Thailand.

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Background: Current choledocholithiasis guidelines heavily focus on patients with low or no risk, they may be inappropriate for populations with high rates of choledocholithiasis. We aimed to develop a predictive scoring model for choledocholithiasis in patients with relevant clinical manifestations.

Methods: A multivariable predictive model development study based on a retrospective cohort of patients with clinical suspicion of choledocholithiasis was used in this study.

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Background: Accurate prognostic prediction of survival in cervical cancer patients with bone metastasis is important for treatment planning. We aimed to externally validate the Matsumiya scoring system using external patient data.

Methods: We collected a retrospective cohort of patients with cervical cancer diagnosed with bone metastasis at Chiang Mai University Hospital from 1st January 2007 to 31st December 2016.

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The effect of sodium-glucose cotransporter-2 inhibitors (SGLT2i) on plasma aldosterone concentration (PAC) and plasma renin activity (PRA) levels are still inconclusive. This meta-analysis aimed to demonstrate the changes in PAC and PRA levels after the use of SGLT2i in type 2 diabetes patients. A search for relevant publications was performed using PubMed/Medline, Scopus, Cochrane, and Embase databases from their inception through May 2022.

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Objective: To compare diagnostic values between the 40 keV virtual monoenergetic plus (40 keV VMI+) dual source dual energy computed tomography (DSDECT) pulmonary angiography images and the standard mixed (90 and 150 kV) images for the detection of acute pulmonary embolism (PE).

Methods: Chest DSDECTs of 64 patients who were suspected of having acute PE were retrospectively reviewed by two independent reviewers. The assessments of acute PE of all patients on a per-location basis were compared between the 40 keV VMI+ and the standard mixed datasets (reference standard) with a two-week interval.

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House dust mite allergen immunotherapy for monosensitized versus polysensitized patients with allergic rhinitis: A systematic review and meta-analysis.

Asian Pac J Allergy Immunol

December 2022

Division of Allergy and Clinical Immunology, Department of Medicine, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand.

Background: Most patients with allergic rhinitis are polysensitized. The efficacy of house dust mite (HDM) allergen immunotherapy (AIT) compared between monosensitized and polysensitized patients remains limited.

Objective: To systematically review the efficacy and safety of HDM AIT compared between monosensitized and polysensitized patients with allergic rhinitis.

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Background: Several studies have demonstrated that the coronavirus disease 2019 (COVID-19) has affected daily living and the healthcare system. No previous study has described the consequences of COVID-19 on emergency department (ED) visits and hospital admission among kidney transplant (KT) recipients.

Aim: To investigate the impact of the COVID-19 pandemic on ED visits and hospital admissions within 1 year in patients who underwent KT in Thailand.

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We aim to develop a diagnostic score for acute cholecystitis that integrates symptoms, physical examinations, and laboratory data to help clinicians for timely detection and early treatment of this disease. We retrospectively collected data from our database from 2010 to 2020. Patients with acute abdominal pain who underwent an ultrasound or computed tomography (CT) scan at the emergency department (ED) were included.

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Direct intracoronary adenosine bolus is an excellent alternative to intravenous adenosine fractional flow reserve (FFR) measurement. This study, during four increasing adenosine boluses (50, 100, 150, and 200 mcg), aimed to explore clinical and angiographic predictors of coronary stenotic lesions for which the significant ischemic FFR (FFR ≤ 0.8) occurred at 150 and 200 mcg adenosine doses.

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Efficacy and safety of house dust mite sublingual immunotherapy tablets in allergic rhinitis: A systematic review and meta-analysis.

World Allergy Organ J

September 2022

Division of Allergy and Clinical Immunology, Department of Pediatrics, Faculty of Medicine, Chiang Mai University, Chiang Mai, Thailand.

Background: House dust mite (HDM) sublingual immunotherapy (SLIT) tablets have been approved for the treatment of patients with allergic rhinitis (AR). However, the meta-analysis on the efficacy of HDM-SLIT tablets for HDM-induced AR patients remained limited.

Methods: Five databases were searched including: PubMed/MEDLINE, EMBASE, Web of Science, the Cochrane Central Register of Controlled Trials, and CINAHL for randomized controlled trials (RCTs) that addressed the efficacy and safetyof HDM-SLIT tablets compared with placebo until January 2022.

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We aimed to evaluate the incremental prognostic value after incorporation of the ankle-brachial index (ABI) into the 10-year pool cohort equation (PCE) risk model in patients with multiple risk factors (MRFs). A total of 4332 MRFs patients were divided into 2 groups as ABI ≤.9 or >.

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Feasibility and Safety of Active Physiotherapy in the Intensive Care Unit for Intubated Patients with Malignancy.

J Rehabil Med

February 2023

Medical intensive care unit APHP Saint Louis, 1 avenue Claude Vellefaux Paris, France.

Objectives: Physiotherapy leads to improvements in critically ill patients who receive mechanical ventilation. However, cancer patients have not been included in previous studies on this subject. This study explored the feasibility and safety of physiotherapy in the intensive care unit for patients with malignancy.

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Surgical treatment in patients with fragility femoral neck fractures often leads to a longer length of hospital stay (LOS) and higher costs. Intensive rehabilitation is one of the choices to reduce LOS, but patient selection criteria are controversial. We intended to develop a clinical score to predict the risk of poor ambulation at discharge.

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Chronic Kidney Disease in a Large National Human Immunodeficiency Virus Treatment Program.

Healthcare (Basel)

August 2022

Division of Endocrinology, Department of Internal Medicine, Faculty of Medicine, Chiang Mai University, Chiang Mai 50200, Thailand.

Article Synopsis
  • Tenofovir disoproxil fumarate (TDF) is linked to a higher risk of chronic kidney disease (CKD), particularly in Asian patients, based on a study involving data from the Thai national health insurance system.
  • In a cohort of 27,313 patients undergoing antiretroviral therapy, the incidence of CKD was found to be low at 0.9%, but those on certain TDF combinations had significantly increased risk compared to those on a standard regimen.
  • Specifically, patients using TDF with lopinavir/ritonavir or nevirapine had a much greater risk of developing CKD compared to those taking alternative treatments.
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Circulating tumor cells (CTCs) play a key role in hematogenous metastasis and post-surgery recurrence. In hepatocellular carcinoma (HCC), CTCs have emerged as a valuable source of therapeutically relevant information. Certain subsets or phenotypes of CTCs can survive in the bloodstream and induce metastasis.

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Background And Aim: The American Society of Gastrointestinal Endoscopy (ASGE) and the European Society of Gastrointestinal Endoscopy (ESGE) have published guidelines for choledocholithiasis. However, the guidelines were formulated using data from a large number of patients with no to low risk of common bile duct (CBD) stones. This study aimed to assess the guidelines' predictive performance in a population with a high frequency of stones.

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Introduction: The study aimed to determine a reference database of the thickness and intraocular thickness asymmetry of total retina, retinal nerve fiber layer (RNFL), ganglion cell layer (GCL), and inner plexiform layer (IPL) in healthy Thai subjects measured by the Spectralis spectral-domain optical coherence tomography.

Methods: This cross-sectional study recruited the healthy subjects age ≥18 years, having spherical refraction within ±6 diopters and cylindrical refraction ±3 diopters, from a hospital's personnel and the people visiting the ophthalmology department. Only 1 eye of each subject was randomly selected for an analysis.

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Unlabelled: To develop and validate a prognostic model, including the minor lymphatic pathway (internal iliac and presacral nodes).

Study Design: Retrospective cohort.

Participants: Locally advanced cervical cancer underwent concurrent chemoradiotherapy.

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To evaluate and validate the minor lymphatic pathway for distant metastases in cervical cancer. This is a retrospective cohort of cervical cancer patients underwent curative concurrent chemoradiotherapy. We used original dataset from 1 university hospital and validation dataset from 3 university hospitals.

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Since current cardiac arrest guidelines do not address the benefit of blood glucose measurement, the ideal ranges and target of blood glucose (BG) levels during cardiac arrest to achieve a better result are warranted. We intended to investigate the associations between intra-arrest BG levels and outcomes of cardiac arrest resuscitation at the emergency department (ED). We conducted a retrospective observational study at a single university hospital.

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Tumor microenvironment exerts a critical role in sustaining homing, retention, and survival of chronic lymphocytic leukemia (CLL) cells in secondary lymphoid organs. Such conditions foster immune surveillance escape and resistance to therapies. The physiological microenvironment is rendered tumor permissive by an interplay of chemokines, chemokine receptors, and adhesion molecules as well as by direct interactions between malignant lymphocytes and stromal cells, T cells, and specialized macrophages referred to as nurselike cells (NLCs).

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Entire Versus Medial Supraclavicular Nodal Irradiation for Patients With High-Risk Node-Positive Breast Cancer.

Int J Radiat Oncol Biol Phys

September 2022

Department of Radiation Oncology, Fudan University Shanghai Cancer Center, Shanghai, China; Department of Oncology, Shanghai Medical College, Fudan University, Shanghai, China; Shanghai Key Laboratory of Radiation Oncology, Shanghai, China. Electronic address:

Purpose: We aimed to examine whether elective inclusion of the posterolateral supraclavicular node (SCL) region to the standard medial SCL target volume improves SCL control and survival outcomes in patients with high-risk node-positive breast cancer undergoing regional nodal irradiation (RNI).

Methods And Materials: We retrospectively reviewed 544 consecutive women with high-risk breast cancer treated with postoperative chest wall/breast and RNI in our center from January 2015 to December 2016. High-risk features were defined as clinical or pathologic stage N2-3b disease.

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